Hypothyroidism With Congenital Heart Disease (CHD)

NCT03496363 | Unknown

• 1 other identifier: CHD
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

Congenital hypothyroidism is one of the most preventable causes of neurocognitive impairment because early treatment is possible in neonates. The thyroid hormone is important for normal growth and development in infancy. After introducing national screening test using capillary thyroid stimulating hormone level, the incidence of untreated congenital hypothyroidism has significantly decreased. According to the Italian Registry of Congenital Hypothyroidism, congenital heart disease is the most frequent disease condition associated with congenital hypothyroidism. Congenital heart disease is also reported to be a risk factor for non-autoimmune hypothyroidism in children. In addition, intravenous iodine contrast media is frequently used for diagnostic imaging and therapeutic intervention in congenital heart disease patients. Excess iodine exposed by iodine contrast media may disturb thyroid function in adult and pediatric population. However, there is no generally accepted guideline for screening thyroid dysfunction in congenital heart disease infants. An increased prevalence of thyroid disease, particularly sub-clinical hypothyroidism, has been reported in Down Syndrome. In children with Down Syndrome, a possible concomitant sub-clinical hypothyroidism-related impairment of cardiac function or structure may worsen their clinical condition and can ultimately affect their life expectancy.

Conditions

Hypothyroidism; CHD

Keywords

Children

Outcome Measures

Primary Outcomes (1)

• EVALUATE THYROID FUNCTION IN PATIENTS WITH CONGENITAL HEART DISEASE

  The study include evaluation of Thyroid function in patients with congenital heart disease coming to cardiology unit - pediatric hospital - Assiut University by measuring TSH and T4 level and detect percentage of hypothyroidism in patients with congenital heart disease.

  May 2018 - May 2020

Secondary Outcomes (1)

• Detect the percentage of patients with congenital heart disease and have no thyroid problems

  May 2018 - May 2020

Study Arms (1)

CHD with Hypothyroidism

Diagnostic Test: TSH , T4

Interventions

TSH , T4 DIAGNOSTIC_TEST

Thyroid stimulating hormone

CHD with Hypothyroidism

Eligibility Criteria

• Age: 1 Day - 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Patients with congenital heart disease

You may qualify if:

• Patients with congenital heart diseases from birth (full term) to 3 years

You may not qualify if:

• Patients with cardiac disease other than congenital heart disease
• Preterm infants
• Patients with other non cardiac congenital anomalies
• Other endocrinal or CNS dysfunction
• Maternal history of thyroid disease or antithyroid management

Sponsors & Collaborators

• Assiut University: lead

Related Publications (11)

• Gruters A, Krude H. Detection and treatment of congenital hypothyroidism. Nat Rev Endocrinol. 2011 Oct 18;8(2):104-13. doi: 10.1038/nrendo.2011.160.

  PMID: 22009163 BACKGROUND

• Rastogi MV, LaFranchi SH. Congenital hypothyroidism. Orphanet J Rare Dis. 2010 Jun 10;5:17. doi: 10.1186/1750-1172-5-17.

  PMID: 20537182 BACKGROUND

• Oerbeck B, Sundet K, Kase BF, Heyerdahl S. Congenital hypothyroidism: influence of disease severity and L-thyroxine treatment on intellectual, motor, and school-associated outcomes in young adults. Pediatrics. 2003 Oct;112(4):923-30. doi: 10.1542/peds.112.4.923.

  PMID: 14523187 BACKGROUND

• Leger J, Larroque B, Norton J; Association Francaise pour le Depistage et la Prevetion des Handicaps de l'Enfant. Influence of severity of congenital hypothyroidism and adequacy of treatment on school achievement in young adolescents: a population-based cohort study. Acta Paediatr. 2001 Nov;90(11):1249-56. doi: 10.1080/080352501317130272.

  PMID: 11808894 BACKGROUND

• American Academy of Pediatrics; Rose SR; Section on Endocrinology and Committee on Genetics, American Thyroid Association; Brown RS; Public Health Committee, Lawson Wilkins Pediatric Endocrine Society; Foley T, Kaplowitz PB, Kaye CI, Sundararajan S, Varma SK. Update of newborn screening and therapy for congenital hypothyroidism. Pediatrics. 2006 Jun;117(6):2290-303. doi: 10.1542/peds.2006-0915.

  PMID: 16740880 BACKGROUND

• Olivieri A, Stazi MA, Mastroiacovo P, Fazzini C, Medda E, Spagnolo A, De Angelis S, Grandolfo ME, Taruscio D, Cordeddu V, Sorcini M; Study Group for Congenital Hypothyroidism. A population-based study on the frequency of additional congenital malformations in infants with congenital hypothyroidism: data from the Italian Registry for Congenital Hypothyroidism (1991-1998). J Clin Endocrinol Metab. 2002 Feb;87(2):557-62. doi: 10.1210/jcem.87.2.8235.

  PMID: 11836285 BACKGROUND

• Passeri E, Frigerio M, De Filippis T, Valaperta R, Capelli P, Costa E, Fugazzola L, Marelli F, Porazzi P, Arcidiacono C, Carminati M, Ambrosi B, Persani L, Corbetta S. Increased risk for non-autoimmune hypothyroidism in young patients with congenital heart defects. J Clin Endocrinol Metab. 2011 Jul;96(7):E1115-9. doi: 10.1210/jc.2011-0057. Epub 2011 Apr 27.

  PMID: 21525159 BACKGROUND

• Barr ML, Chiu HK, Li N, Yeh MW, Rhee CM, Casillas J, Iskander PJ, Leung AM. Thyroid Dysfunction in Children Exposed to Iodinated Contrast Media. J Clin Endocrinol Metab. 2016 Jun;101(6):2366-70. doi: 10.1210/jc.2016-1330. Epub 2016 Mar 28.

  PMID: 27018967 BACKGROUND

• Ahmet A, Lawson ML, Babyn P, Tricco AC. Hypothyroidism in neonates post-iodinated contrast media: a systematic review. Acta Paediatr. 2009 Oct;98(10):1568-74. doi: 10.1111/j.1651-2227.2009.01412.x. Epub 2009 Jul 3.

  PMID: 19575766 BACKGROUND

• Lee SY, Rhee CM, Leung AM, Braverman LE, Brent GA, Pearce EN. A review: Radiographic iodinated contrast media-induced thyroid dysfunction. J Clin Endocrinol Metab. 2015 Feb;100(2):376-83. doi: 10.1210/jc.2014-3292. Epub 2014 Nov 6.

  PMID: 25375985 BACKGROUND

• Toscano E, Pacileo G, Limongelli G, Verrengia M, Di Mita O, Di Maio S, Salerno M, Del Giudice E, Caniello B, Calabro R, Andria G. Subclinical hypothyroidism and Down's syndrome; studies on myocardial structure and function. Arch Dis Child. 2003 Nov;88(11):1005-8. doi: 10.1136/adc.88.11.1005.

  PMID: 14612370 BACKGROUND

MeSH Terms

Conditions

Hypothyroidism

Condition Hierarchy (Ancestors)

Thyroid Diseases; Endocrine System Diseases

Central Study Contacts

Nagwa Ali Mohamed, Professor

CONTACT

01096260950; Nagwa.Abdelaal@med.au.edu.eg

Mohamed El Ameer Fathy Riad, Assisstant Professor

CONTACT

01005689353; mohamed_osman@med.au.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 10, 2018
• First Posted: April 12, 2018
• Study Start: May 1, 2018
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2020
• Last Updated: April 12, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share